Irbesartan is a generic blood pressure medication that was recalled because it may contain a toxic cancer-causing impurity known as N-nitrosodiethylamine (NDEA).

Need a Texas Irbesartan Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with cancer or another severe side effect, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.

UPDATE: Irbesartan Recall Expanded for Cancer-Causing Impurity

In January 2019, a recall was issued for 1 lot of irbesartan and 7 lots of irbesartan and hydrochlorothiazide (HCTZ) pills distributed by Solco Healthcare LLC due to unacceptable amounts of N-Nitrosodiethylamine (NDEA).

For a complete list of irbesartan medications under recall, please click here.

The expanded recall involves the products listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle.

ProductNDC CodeLot NumberExpiry DatesDistribution Date
IRBESARTAN TABLETS 300MG 90CT43547-376-09331B1800902/20218/9/2018
IRBESARTAN/HCTZ
300MG/12.5MG 30CT TABLETS
43547-331-03327A1800103/20217/10/2018
IRBESARTAN/HCTZ
300MG/12.5MG 30 CT TABLETS
43547-331-03327A1800203/20217/10/2018
IRBESARTAN/HCTZ 300MG/12.5MG 90CT
TABLETS
43547-331-09327B1800803/20217/10/2018
IRBESARTAN/HCTZ 300MG/12.5MG 90CT
TABLETS
43547-331-09327B1800903/20217/10/2018
IRBESARTAN/HCTZ 150MG/12.5MG 30CT43547-330-03325D1800403/20217/10/2018
IRBESARTAN/HCTZ
150MG/12.5MG 90CT TABLETS
43547-330-09325B1800403/20218/24/2018
IRBESARTAN/HCTZ 150MG/12.5MG 30CT
TABLETS
43547-330-03325D1800503/20217/10/2018

What is Irbesartan?

Irbesartan is a generic medication that is prescribed for the treatment of high blood pressure (hypertension) and certain patients with kidney disease.

Types of Irbesartan

It is sold by different pharmaceutical companies, alone or in combination with other drugs. The brand-names of Irbesartan include:

  • Avapro
  • Avalide
  • Karvea
  • Irbesartan (Generic)

What is the Problem?

Patients who take certain types of Irbesartan may be at risk of cancer or other side effects due to a toxic chemical impurity left over from the drug’s manufacturing process. The problem was only discovered recently, but patients may have been at risk for many years.

Irbesartan Recalls

In January 2019, Prinston Pharmaceutical Inc., doing business as Solco Healthcare LLC., recalled one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets due to the detection of NDEA above the acceptable daily intake levels released by the FDA.

In October 2018, Aurobindo Pharma Limited issued the first recall for Irbesartan due to the impurity, a carcinogenic chemical called N-nitrosodiethylamine (NDEA).

SciGen Pharmaceuticals, Inc. recalled Irbesartan Tablets, USP (75-mg, 150-mg, and 300-mg dosage) due to the presence of NDEA. The products were labeled as “Westminster Pharmaceuticals” and “Golden State Medical Supply, Inc. (GSMS).”

Blood Pressure Drug Recalls

Recalls have been issued for Valsartan and Losartan, as well as Irbesartan, due to the presence of NDEA and other toxic impurities

What is NDEA?

N-nitrosodiethylamine (NDEA) is a carcinogenic (cancer-causing) chemical that is found in air pollution. It is also a byproduct of the industrial processes that are used to make Irbesartan and other medications. NDEA is listed as a “probable human carcinogen” by the International Agency for Research on Cancer (IARC).

What Should I Do?

If you are taking a recalled Irbesartan medication, the FDA recommends talking to your doctor about switching regimens. Do not stop taking your medications without talking to your doctor first, because suddenly stopping Irbesartan could cause health problems.

Irbesartan Lawsuits

Our lawyers are investigating potential lawsuits for people who took Irbesartan and developed cancer or other severe side effects. We hold drug-makers accountable for selling defective drugs, failing to warn about severe side effects, and putting profits over patients safety.

Need an Irbesartan Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.

Meet Your Attorney

Collen A. Clark

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

“Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

To contact Collen, please fill out the contact form below:

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